Implant, systems and methods for physically diverting material in blood flow away from the head

Abstract

A device for preventing stroke due to embolic material in the bloodstream of a patient, the patient having an aorta with an ascending portion and a descending portion, and one or more arch vessels communicating with the aorta for directing blood flow to the brain of the patient. The device includes a physical deflector element configured for at least partial placement in the aorta of the patient and a mounting structure coupled to the physical deflector element. The mounting structure is configured to engage at least one of the aorta or an arch vessel communicating with the aorta. The physical deflector element is constructed and arranged to direct blood flow in the aorta in a manner that directs embolic material in the blood flow past the one or more arch vessels and into the descending portion of the aorta.

1 . A device for preventing stroke due to embolic material in the bloodstream of a patient, the patient having an aorta with an ascending portion and a descending portion, and one or more arch vessels communicating with the aorta for directing blood flow to the brain of the patient, the device comprising:
 a physical deflector element configured for at least partial placement in the aorta of the patient, and   mounting structure coupled to the physical deflector element, the mounting structure configured to engage at least one of the aorta or an arch vessel communicating with the aorta,   wherein the physical deflector element is constructed and arranged to direct blood flow in the aorta in a manner that directs embolic material in the blood flow past the one or more arch vessels and into the descending portion of the aorta.   
   
   
       2 . The device of  claim 1 , wherein the physical deflector element further comprises at least one generally tubular member. 
   
   
       3 . The device of  claim 2 , wherein the generally tubular member is curved to generally follow an arch in the aorta. 
   
   
       4 . The device of  claim 2 , wherein the generally tubular member is configured for mounting within one of the arch vessels communicating with the aorta such that a portion of the generally tubular member extends within the aorta. 
   
   
       5 . The device of  claim 2 , wherein the generally tubular member further comprises multiple tubular portions. 
   
   
       6 . The device of  claim 2 , wherein the generally tubular member includes at least one non-tubular portion. 
   
   
       7 . The device of  claim 1 , wherein the physical deflector element further comprises a shield member constructed and arranged to shield at least one entrance to an arch vessel and redirect blood flow away from the entrance. 
   
   
       8 . The device of  claim 7 , further comprising a generally tubular member coupled with the shield member, the generally tubular member allowing retrograde flow of blood to the entrance of the arch vessel. 
   
   
       9 . The device of  claim 1 , wherein the physical deflector element further comprises a ramp member. 
   
   
       10 . The device of  claim 1 , wherein the physical deflector element further comprises at least one element that causes a generally spiral or whirling blood flow in the aorta. 
   
   
       11 . The device of  claim 1 , wherein the physical deflector element further comprises a plurality of shield elements. 
   
   
       12 . The device of  claim 1 , wherein the physical deflector element further comprises a flow restricting element. 
   
   
       13 . The device of  claim 12 , further comprising a generally tubular member coupled with the flow restricting element. 
   
   
       14 . The device of  claim 13 , wherein the generally tubular member further comprises a blood flow inlet and a blood flow outlet, and the flow restricting element is mounted closer to the blood flow inlet than to the blood flow outlet. 
   
   
       15 . The device of  claim 1 , wherein the mounting structure further comprises a stent-like structure for engaging an inner wall of an arch vessel or an inner wall of the aorta, or both the inner wall of the arch vessel and the inner wall of the aorta. 
   
   
       16 . The device of  claim 1 , wherein the mounting structure further comprises at least one of: a stent-like structure, hooks, barbs, spring elements, adhesive, suture, fabric or an aortic graft. 
   
   
       17 . The device of  claim 1 , wherein the physical deflector element is collapsible for delivery through the arterial system of the patient and expandable for deployment at least partially in the aorta. 
   
   
       18 . The device of  claim 1 , wherein the physical deflector element further comprises a tubular aortic graft constructed and arranged to replace a portion of the aorta. 
   
   
       19 . The device of  claim 18 , further comprising at least one tubular arch vessel graft coupled with the aortic graft and configured to supply blood flow to at least one arch vessel of the patient. 
   
   
       20 . A device for preventing stroke due to embolic material in the bloodstream of a patient, the patient having an aorta with an ascending portion and a descending portion, and one or more arch vessels communicating with the aorta for directing blood flow to the brain of the patient, the device comprising:
 a generally tubular physical deflector element configured for placement in the aorta of the patient, the generally tubular physical deflector element having an entrance for receiving blood flow from the ascending portion of the aorta and an exit for directing blood flow into the descending portion of the aorta,   mounting structure coupled to the generally tubular physical deflector element, the mounting structure configured to engage the aorta and/or an arch vessel communicating with the aorta, and   a flow restricting element mounted to the generally tubular deflector element and configured to direct a first portion of the blood flow through the entrance and a second portion of the blood flow around the generally tubular physical deflector element to the one or more arch vessels.   
   
   
       21 . The device of  claim 20 , wherein the generally tubular physical deflector element is curved to generally follow an arch in the aorta between the ascending portion and the descending portion. 
   
   
       22 . The device of  claim 21 , wherein the mounting structure further comprises at least one of: a stent-like structure, hooks, barbs, spring elements, adhesive, suture, fabric, or an aortic graft. 
   
   
       23 . A method of physically directing embolic material in blood flow within the aorta away from an arch vessel communicating with the aorta, the method comprising:
 mounting a physical deflector element at least partially within the aorta,   using the physical deflector element to direct a first portion of the blood flow past an entrance of the arch vessel, and   directing a second portion of the blood flow to the entrance of the arch vessel.   
   
   
       24 . The method of  claim 23 , wherein directing the second portion of the blood flow further comprises:
 directing the second portion of the blood flow at least partially in a retrograde manner.   
   
   
       25 . The method of  claim 23 , wherein using the physical deflector element to direct the first portion of the blood flow further comprises:
 directing the first portion of the blood flow through a generally tubular member.   
   
   
       26 . The method of  claim 23 , wherein using the physical deflector element to direct the first portion of the blood flow further comprises:
 directing the first portion of the blood flow against a ramp member.   
   
   
       27 . The method of  claim 23 , wherein using the physical deflector element to direct the first portion of the blood flow further comprises:
 directing the first portion of the blood flow in a generally spiral manner through the aorta.   
   
   
       28 . The method of  claim 23 , wherein using the physical deflector element to direct the first portion of the blood flow further comprises:
 directing the first portion of the blood flow against a plurality of shield members.   
   
   
       29 . The method of  claim 23 , wherein using the physical deflector element to direct the first portion of the blood flow further comprises:
 shielding the entrance of the arch vessel to prevent the arch vessel from receiving the first portion of the blood flow.   
   
   
       30 . The method of  claim 29 , wherein directing the second portion of the blood flow further comprises:
 directing the second portion in a retrograde manner through a generally tubular member within the aorta.   
   
   
       31 . The method of  claim 23 , wherein using the physical deflector element to direct the first portion of the blood flow further comprises:
 mounting a generally tubular member within the arch vessel such that a portion thereof extends into the aorta.   
   
   
       32 . The method of  claim 23 , wherein the physical deflector element further comprises a generally tubular member having an entrance end, and using the physical deflector element to direct the first portion of the blood flow further comprises:
 mounting the generally tubular member such that the entrance end communicates with a peripheral portion of the blood flow in an ascending portion of the aorta generally adjacent to the aortic valve of the heart, and   directing the second portion of the blood flow into the entrance end.   
   
   
       33 . The method of  claim 23 , wherein the physical deflector element further comprises a generally tubular member having an entrance end, and using the physical deflector element to direct the first portion of the blood flow further comprises:
 mounting the generally tubular member such that the entrance end communicates with a central portion of the blood flow in an ascending portion of the aorta generally adjacent to the aortic valve of the heart, and   directing the first portion of the blood flow into the entrance end.   
   
   
       34 . A method of replacing a portion of the aorta of a patient with a tubular aortic graft having at least one tubular arch vessel graft coupled thereto, the method performed in a manner that lessens the occurrence of stroke due to embolic material flowing to the brain of the patient and comprising:
 replacing a portion of the aorta with the tubular aortic graft such that the tubular arch vessel graft is misaligned with an arch vessel of the patient, and   connecting the misaligned tubular arch vessel graft with the arch vessel.   
   
   
       35 . The method of  claim 34 , wherein the tubular aortic graft includes an ascending portion, a descending portion, and an arch portion between the ascending and descending portions, the arch portion having an outer larger radius curved portion and an inner smaller radius curved portion, wherein the misaligned tubular arch vessel graft is connected to the inner smaller radius curved portion. 
   
   
       36 . The method of  claim 34 , wherein the tubular aortic graft includes an ascending portion, a descending portion, and an arch portion between the ascending and descending portions, wherein the misaligned tubular arch vessel graft is connected to the ascending portion adjacent to an aortic valve of the heart. 
   
   
       37 . The method of  claim 34 , wherein the tubular aortic graft includes an ascending portion, a descending portion, and an arch portion between the ascending and descending portions, wherein the misaligned tubular arch vessel graft is connected to the descending portion generally adjacent to the inner smaller radius curved portion of the arch. 
   
   
       38 . A method of physically directing embolic material in blood flow within the aorta away from an arch vessel communicating with the aorta, the method comprising:
 mounting a flow restricting element within the aorta downstream of the aortic valve of the patient,   directing a first portion of the blood flow through the flow restricting element and past an entrance to the arch vessel, and   directing a second portion of the blood flow to the entrance to the arch vessel.   
   
   
       39 . The method of  claim 38 , wherein the first portion of the blood flow is directed at a higher velocity than the second portion of the blood flow. 
   
   
       40 . The method of  claim 38 , wherein the flow restricting element is mounted to a generally tubular member and the method further comprises:
 directing the first portion of the blood flow through the generally tubular member, and   directing the second portion of the blood flow around an outside of the generally tubular member.   
   
   
       41 . A method of physically directing embolic material in blood flow within the aorta away from an arch vessel communicating with the aorta, the method comprising:
 inserting a collapsed deflector element partially within the arch vessel from within the aorta, and   expanding the collapsed deflector element against an inner wall of the arch vessel such that a first portion of the expanded deflector element is within the arch vessel and a second portion of the expanded deflector element is within the aorta.   
   
   
       42 . The method of  claim 41 , further comprising:
 using a shield member within the aorta and downstream of the arch vessel during at least one of the inserting and expanding steps to deflect embolic material away from another arch vessel.   
   
   
       43 . The method of  claim 41 , further comprising:
 percutaneously performing the inserting and expanding steps using one or more catheter devices.   
   
   
       44 . The method of  claim 41 , wherein the first portion of the expanded deflector element comprises at least one blood flow opening and the method further comprises:
 generally aligning the blood flow opening with another vessel entrance communicating with the arch vessel.   
   
   
       45 . A system for preventing stroke due to embolic material in the bloodstream of a patient, the patient having an aorta with an ascending portion and a descending portion, and one or more arch vessels communicating with the aorta for directing blood flow to the brain of the patient, the system comprising:
 at least one catheter device,   a physical deflector element configured for at least partial placement in the aorta of the patient, and   mounting structure coupled to the physical deflector element, the mounting structure configured to engage at least one of the aorta or an arch vessel communicating with the aorta,   wherein the physical deflector element is constructed and arranged to direct blood flow in the aorta in a manner that directs embolic material in the blood flow past the one or more arch vessels and into the descending portion of the aorta, and the catheter device is used to deliver the physical deflector element and/or the mounting structure to the aorta and/or to the vessel.